Medical Director, Global Medical Affairs
hace 1 semana
Location: Barcelona, Spain
Job reference: R-201624
Date posted: 06/06/2024
**This is what you will do**:
Reporting to the Senior Director, the Global Medical Director will provide support for strategic planning and leadership for hematology and nephrology indications and expanding pipeline portfolio. Responsible for providing scientific and medical support with an in-depth understanding of the medical landscape. Support the development and implementation of long-term strategy with effective cross-functional collaboration. Support the Alexion Global Medical Affairs mission to maximize patient outcomes by setting and continuously advancing the evidence-based medical standard of care.
**You will be responsible for**:
In collaboration with the SD, develop and implement global medical TA strategy and plan for GMA activities (pre-launch and post -launch as applicable) for the specified therapeutic area by providing medical leadership, insight and strategy to TA global medical affairs team across functions and countries globally.
Responsible for the following:
- Contributing to the situational assessment and the global product strategy development including harmonization of activities involving KOLs.
- Contributing to in-year global medical strategy, Implementation and budget plan for global initiatives
- Providing medical strategic recommendation for in-line life cycle management (LCM) and late phase pipeline programs
- Contributing to Phase 3b/ 4 and ESR evidence generation strategy for late phase pipeline and in-line TA programs
- Developing and overseeing clinical study design (non-registration phase IIIb/ IV, registries, outcomes research etc.) for late phase pipeline and in-line TA programs in close collaboration with relevant functions
- Providing medical review and ensure alignment with TA strategy of Externally sponsored research (ESR) proposals including the review of the Final Report
- Providing clear strategic guidance to scientific communication, internal medical training, external medical education (CME, Symposia, medical education), medical info, PEVT teams in developing functional plans supporting global medical strategy
- Providing global medical guidance to country medical teams in developing country medical plans aligned with global medical strategy
- Collaborating with country medical TA lead to ensure local activities are aligned with global medical strategy and that Global Medical is sufficiently aware of country insights and needs. Alignment among Global and Country Medical Plans, adjust if needed.
Serves as the medical expert and resource within ALXN in support of the therapeutic area. Responsible for the following:
- Contributing to and lead when appropriate content development and presentation for external medical education programs, and other Global Medical initiatives
- Contributing to and participate in therapeutic training programs for Alexion personnel.
- Medical affairs review of field medical tools, internal commercial training material. - Pending MLR Workstream recommendations
- Contributing to Medical affairs review of post approval regulatory responses and annual safety reports
- Contributing to Medical affairs review of reimbursement dossiers
- Medical affairs review of congress abstracts and publications
Establishes strategic partnerships with centers of excellence and KOLs in areas of scientific interest and serves as conduit for flow of information both out to the medical community and into the company. Responsible for the following:
- Development and execution of Global KOL medical engagement strategy
- Providing TA KOL engagement strategy and guidance to country medical teams in developing country KOL engagement plans
- Establishing and/or enhance partnerships with key academic institutions and develop relationships with global key thought leaders
- Planning, designing and managing global medical Advisory Boards and gather insight from regional/local medical Advisory Boards
Responsible for the Global and Country Quarterly Management Review and will be consulted on defining Country-Specific Medical Plan.
**You will need to have**:
- Must have a PhD, PharmD or MD level degree or equivalent
- 1-4 years + experience in medical affairs organization ( med info, grant processing, field MSL team, KOL management, scientific communications)
- Experience in Medical Affairs function
- Excellent communication skills both written and verbal.
- Regulatory and compliance experience in a Medical Affairs organization
- Excellent interpersonal skills with demonstrated track record and ability to drive results as an effective a team member and project leader
- Previous Clinical Operations experience (design and implementation of clinical trials)
- Proven ability to manage budget and resources
- Strong business acumen
- Ability to build partnerships cross-functionally
- Flexibility and ability to adapt to changing conditions
- Excellent problem solving, organizational, and negotia
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